A Multicenter, Double-Blind, Randomized, Comparative Study To Evaluate The Safety, Tolerability, And Efficacy Of MK-0991 Versus (Amphotericin B) Liposome For Injection As Empirical Therapy In Patients With Persistent Fever And Neutropenia
- Compare the number of successful treatment outcomes among patients treated with
caspofungin acetate vs amphotericin B liposomal for persistent fever and neutropenia
following cancer therapy, in terms of survival for 7 days after study drug, resolution
of fever, treatment of any baseline fungal infection, absence of breakthrough fungal
infection during and for 7 days after study drug, and absence of study drug
discontinuation due to toxicity or lack of efficacy.
- Compare the incidence of nephrotoxicity in patients treated with these regimens.
- Compare the incidence of infusion-related adverse events within 1 hour of the infusion
in patients treated with these regimens.
- Compare the incidence of treatment discontinuation due to drug-related adverse events,
frequency of drug-related events, number of breakthrough fungal infections, and number
of successfully treated baseline fungal infections in patients treated with these
- Compare incidence of required dose increase due to inadequate clinical response in
patients treated with these regimens.
- Compare the time to resolution of fever in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to high-risk (prior allogeneic bone marrow transplantation or prior
chemotherapy for relapse of acute leukemia) vs low-risk and prior prophylactic antifungal
therapy during chemotherapy (yes vs no). Patients are randomized to one of two treatment
- Arm I: Patients receive caspofungin acetate IV over 1 hour followed by placebo IV over
- Arm II: Patients receive placebo IV over 1 hour followed by amphotericin B liposomal IV
over 2 hours.
Treatment repeats daily for up to 28 days in the absence of disease progression or
Patients are followed at 7 and 14 days after study drug discontinuation.
PROJECTED ACCRUAL: A total of 1060 patients (530 per arm) will be accrued for this study.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Kent Sepkowitz, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
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